1.4.3.1 Industry-academia: Research as service

Background and Expectations

A significant percentage of drug discovery and development efforts is outsourced to external service providers. Biopharmaceutical industry aims to achieve the same robustness and reliability of research data whether originating from internal laboratories or external collaboration partners.

With this objective in mind, EQIPD has developed experimental record-keeping guidelines for organizations performing non-regulated research under contractual agreement conditions. The practices outlined are intended to safeguard data traceability and data integrity, to facilitate decision making and create reliable scientific evidence to bring the best possible solutions to patients.

Further, EQIPD has developed a tool that allows assessment of research practices at organizations conducting research as a service (e.g., contract research organizations). This tool is used by sponsors of research to quality service providers prior to concluding the legal contracting paperwork.

The tool may also be used by both sponsors and service providers to trigger a more in-depth assessment of research practices by the EQIPD team.

Resources

EQIPD experimental record-keeping guidelines

• one-pager
• full-length

Service provider assessment tool

• Excel-based tool (The tool can be downloaded from the Online-Excel via the tap “File” in the menu, click on “Save as” and click on "Download as")